Evaluating the Performance of Precision1 Daily Disposable Contact Lens in a Group of Heavy Digital Device Users (PUG)

The purpose of this study is to evaluate the performance of Precision1 DD CLs with regard to subjective symptoms (dryness, comfort, vision), lens fit and time to haze in CL wearers who identify themselves as heavy digital devices users (at least 6 hours of digital device use per day).

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Verofilcon A contact lenses

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Ocular Research & Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Is between 18 and 40 years of age (inclusive) and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Is a heavy digital device user (at least 6 hours on a typical day using any combination of digital devices such as PC, laptop, smartphone, or tablet);
5. Is a habitual wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision, not a current wearer of Precision1 lenses) for at least 5 days/week and at least 10 hours/day during the month prior to enrollment;
6. Has a vertex corrected spherical equivalent distance refraction that ranges between -0.50D to -6.00D in each eye;
7. Has a vertex corrected refractive cylinder of no more than -1.00D cylindrical correction in each eye after vertexing to the corneal plane;
8. Demonstrates an acceptable fit and achieves best corrected visual acuity of at least 0.20 log MAR in each eye with Precision1 contact lenses;
9. Is willing to wear Precision1 CLs at least 5 days per week and 10 hours per day throughout the study;

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Is aphakic;

8. Has undergone refractive error surgery;

   • For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Refit; Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance.	Device: Verofilcon A contact lenses; Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia); Other Names: Precision1™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Comfort After Contact Lens Insertion	Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).	Dispense Visit (Day 0)
Subjective Dryness After Contact Lens Insertion	Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).	Dispense Visit (Day 0)
Subjective Rating of Clarity of Vision After Contact Lens Insertion	Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).	Dispense Visit (Day 0)
Subjective Comfort After Contact Lens Insertion	Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).	Day 1
Subjective Dryness After Contact Lens Insertion	Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).	Day 1
Subjective Rating of Clarity of Vision After Contact Lens Insertion	Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).	Day 1
Subjective Comfort After Contact Lens Insertion	Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).	Day 7
Subjective Dryness After Contact Lens Insertion	Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).	Day 7
Subjective Rating of Clarity of Vision After Contact Lens Insertion	Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).	Day 7
Subjective Comfort After Contact Lens Insertion	Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).	Day 10
Subjective Dryness After Contact Lens Insertion	Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).	Day 10
Subjective Rating of Clarity of Vision After Contact Lens Insertion	Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).	Day 10
Subjective Comfort After Contact Lens Insertion	Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).	Followup visit (occurring at a single visit any day from Day 12-16)
Subjective Dryness After Contact Lens Insertion	Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).	Followup visit (occurring at a single visit any day from Day 12-16)
Subjective Rating of Clarity of Vision After Contact Lens Insertion	Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).	Followup visit (occurring at a single visit any day from Day 12-16)
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Day 1
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Day 1
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Day 1
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Day 7
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Day 7
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Day 7
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Day 10
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Day 10
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Day 10
Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Followup visit (occurring at a single visit any day from Day 12-16)
Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Followup visit (occurring at a single visit any day from Day 12-16)
Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use	Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).	Followup visit (occurring at a single visit any day from Day 12-16)
Subjective Comfort at End of Day With Contact Lens Wear	Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).	Day 1
Subjective Dryness at End of Day With Contact Lens Wear	Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).	Day 1
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear	Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best).	Day 1
Subjective Comfort at End of Day With Contact Lens Wear	Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).	Day 7
Subjective Dryness at End of Day With Contact Lens Wear	Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).	Day 7
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear	Participants rate their end of day rating of vision clarity on a scale from 0 (worst) to 100 (best).	Day 7
Subjective Comfort at End of Day With Contact Lens Wear	Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).	Day 10
Subjective Dryness at End of Day With Contact Lens Wear	Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).	Day 10
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear	Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best).	Day 10
Subjective Comfort at End of Day With Contact Lens Wear	Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).	Followup visit (occurring at a single visit any day from Day 12-16)
Subjective Dryness at End of Day With Contact Lens Wear	Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).	Followup visit (occurring at a single visit any day from Day 12-16)
Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear	Participants rate their end of day rating of vision clarity on a scale from 0 (worst) to 100 (best).	Followup visit (occurring at a single visit any day from Day 12-16)

Collaborators and Investigators

• Sponsor: University of Waterloo
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2019
• Primary Completion (Actual): September 27, 2021
• Study Completion (Actual): September 27, 2021

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: December 13, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 41694

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes